Kornimate/medical-research-clean huggingface dataset:
diagnostic and prognostic value of p16ink4a expression in low grade squamous intraepithelial lesions of the cervix.

Conditions: Cervical Intraepithelial Neoplasia Grade 1 (CIN 1)

Summary: p16ink4a has recently been described as a surrogate marker for hr-hpv associated squamous and glandular intraepithelial lesions of the cervix. the immunohistochemical staining pattern of p16ink4a in high grade intraepithelial neoplasia of the cervix (cin 2 and 3) is diffuse, whereas in cin 1 different staining patterns (diffuse, sporadic, focal or negative) can be seen. the aim of our study is to find out whether the p16ink4a staining pattern of cin 1 is able to predict the outcome of the lesion. the retrospective part of the study includes cervical biopsies of 200 patients with cin 1 and clinical follow-up for at least 5 years. p16ink4a staining and hpv detection by ihc will be correlated to clinical outcome.the prospective part of the study includes 300 patients with cin 1 and lsil on cytology. hpv detection by hcii and p16ink4a immunohistochemistry on liquid based cytology samples as well as p16ink4a staining and hpv detection by ish on colposcopy guided biopsies will be correlated to clinical follow-up and colposcopy findings. slides are analysed by 2 pathologists without knowledge of clinical data.


Eligibility criteria:
responsible women \> 18 years with histologically proven cin 1

Keywords: prognostic value of p16ink4a cin 1 lsil hpv
nowdx test for the detection of antibodies to covid-19

Conditions: COVID-19; SARS-CoV-2; Coronavirus

Summary: this study is designed to compare the performance of the nowdx covid-19 test to an emergency use authorized pcr test result. the intent is to show the rapid test device is comparable to a currently marketed device. the nowdx covid-19 test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to sars-cov-2 in human whole blood (venous and fingerstick).

this study is designed to compare the performance of the nowdx covid-19 test to an emergency use authorized pcr test result. the intent is to show the rapid test device is comparable to a currently marketed device. the nowdx covid-19 test is an in vitro lateral flow immunoassay intended for qualitative detection of total antibodies to sars-cov-2 in human whole blood (venous and fingerstick). the nowdx covid-19 test is intended for use as an aid in identifying individuals with an adaptive immune response to sars-cov-2, indicating recent or prior infection. at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. testing of human venous whole blood (edta) and fingerstick specimens are intended to be conducted in patient care settings authorized to perform clia waived tests.

Eligibility criteria:
inclusion criteria: * persons ≥18 years old; * persons who have tested positive or negative (within 6 days) for covid-19 with an emergency use authorized molecular (pcr) test and can furnish said test report. exclusion criteria: * persons \<18 years old; * persons who have previously participated in a nowdx study.
comparisonbetween primary hypertension monitoring methods for detection of early kidney dysfunction

Conditions: Primary Hypertension

Summary: the present study aims to show the difference of blood pressure monitored centrally and automated bp monitoring among patients with primary hypertension for early detection of kidney dysfunction

hypertension is well known as the silent killer, there is a close relationship between blood pressure levels and the risk of cardiovascular events, strokes and kidney disease. diabetes and hypertension cause up to two-thirds of chronic kidney disease , chronic kidney disease is a common condition characterized by evidence of kidney damage or dysfunction. chronic kidney disease is currently classified based on a patient's estimated glomerular filtration rate and urinary albumin excretion rate , clinicians look for markers of renal damage (e.g., abnormalities of urinary sediment or organ structure) to diagnose chronic kidney disease in people with estimated glomerular filtration rate of \<60 ml/min/1.73 m2. age distribution for hypertension showed progressive rise in blood pressure with increasing age. age-related hypertension appears to be predominantly systolic rather than diastolic. the third nhanes survey reported that the prevalence of hypertension grows significantly with increasing age in all sex and race groups. in another study, the incidence of hypertension appeared to increase approximately 5% for each 10-year interval of age because central blood pressure is considered better than peripheral blood pressure in predicting cardiovascular events, due to wave reflections and viscoelastic properties of the arterial wall now a day several non-mercury techniques have been developed during the last ten years in order to gradually supplant the mercury-auscultatory method, such as the automatic electronic devices using algorithms based on the oscillometric technique. over the last ten years , different protocols are used to validate the accuracy of blood pressure measuring devices , several automated devices have been successfully validated using established protocols.

Eligibility criteria:
inclusion criteria: 1. age between 40 years to 70 years old . 2. patients who have history of primary hypertension either on medical treatment or not . exclusion criteria: 1. all patients with 2ry hypertension. 2. diabetic patients. 3. patients with esrd on regular dialysis . 4. patients with creatinineclearance \>30ml/min . 5. collagen diseases
acuvue® oasys® 1-day vs dailies total1®

Conditions: Refractive Error

Summary: the purpose of this study is to compare the lens fit characteristics, specifically lens centration, of acuvue® oasys® 1-day (ao1d) contact lenses and dailies total1® (dt1) contact lenses.


Eligibility criteria:
inclusion criteria: * must sign informed consent form; * adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day; * symptoms of contact lens discomfort as defined by the symptomatology (eligibility) pre-screening questionnaire; * prescription within -1.00 diopter (d) to -6.00d to be fitted with study contact lenses; * cylinder equal or lower than -0.75d in both eyes; * vision correctable to 20/25 or 0.1 logmar (logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at visit 1; * can be successfully fitted with both study lenses at visit 1; * willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits; * other protocol-specified inclusion criteria may apply. exclusion criteria: * ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear; * use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator; * monocular (only 1 eye with functional vision) or fit with only 1 lens; * fitted with monovision; * prior refractive surgery; * history of herpetic keratitis, ocular surgery, or irregular cornea; * pregnant or lactating; * use of mechanical eyelid therapy or eyelid scrubs within 14 days before visit 1 and not willing to discontinue during the study; * participation in any clinical study within 30 days of visit 1; * current dt1 or ao1d lens wearer; * other protocol-specified exclusion criteria may apply.
remission induction and sustenance in graves' disease 2

Conditions: Graves Disease; Hyperthyroidism

Summary: atd therapy for graves' disease is one of the commonly used options for therapy of the hyperthyroidism. the investigators study how to optimally keep patients in remission.

a detailed description of patients entering the initial observational phase of the study (risg1) has been published: laurberg p, nygaard b, andersen s, carlé a, karmisholt j, krejbjerg a, pedersen ib, andersen sl. association between tsh-receptor autoimmunity, hyperthyroidism, goitre, and orbitopathy in 208 patients included in the remission induction and sustenance in graves' disease study. j thyroid res. 2014;2014:165487. doi: 10.1155/2014/165487.

Eligibility criteria:
inclusion criteria: * graves hyperthyroidism in remission after atd exclusion criteria: * age \< 18, severe concomitant disease
infusion of a single dose of erythropoietin to prevent injury in an ischemia reperfusion forearm model

Conditions: Ischemia-Reperfusion Injury; Myocardial Infarction

Summary: rationale: the investigators hypothesize that epo protects against apoptosis after acute ischemia in man and that it is detectable using the annexin-a5 model. objective: does infusion of a single dose of epoetin alfa, a short-acting epo, protect against apoptosis in man after acute ischemia? study design: a double blinded randomised cross-over study. study population: 12 healthy male volunteers, between 18 and 40 years old. intervention: all 12 volunteers will receive a single dose of epo and placebo in a randomized order. a six week wash-out period is obtained in order to avoid interference of both treatments. main study parameters/endpoints: the percentage of difference between radioactivity (quantified as counts per pixel) of the experimental and control thenar muscle at one and four hours after reperfusion.


Eligibility criteria:
inclusion criteria: * healthy volunteers between 18 and 40 years of age * male * volunteers are not allowed smoking 24 hours before the start of the experiment exclusion criteria: * female * hypertension (sbp \>140 mmhg, dbp \>90 mmhg) * diabetes mellitus (dm) (fasting glc \>6.9 mmol/l, glc \>11.0 mmol/l) * hypercholesterolemia * renal dysfunction (egfr \< 60 ml/min, calculated using mdrd formula) * any known hypersensitivity/allergic reaction to one of the constituents of epoetin alfa * a history of use of any form of epo * any current medication use * cardiovascular disease in medical history * smoking less than 24 hours prior to epoetin alpha infusion * participation in research in the last 5 years in which any form of radioactivity was used * no participation in any research trial in the last 30 days or 5 times the half-life of the used substance

Keywords: apoptosis annexin hypoxia ischemia-reperfusion injury
phase iii randomized, double-blind, placebo-controlled study of dehydroepiandrosterone replacement for primary adrenal insufficiency

Conditions: Addison's Disease

Summary: objectives: i. determine the efficacy of dehydroepiandrosterone (dhea), an androgen replacement hormone, for patients with primary adrenal insufficiency (addison's disease).

protocol outline: this is a randomized, double-blind study. patients are stratified by age. patients are randomly assigned to androgen replacement therapy with daily dehydroepiandrosterone (dhea) or placebo for 6 months. all patients may receive 6 additional months of dhea following randomized therapy. women on hormonal replacement therapy may receive concurrent conjugated estrogens or oral medroxyprogesterone.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- primary adrenal insufficiency (addison's disease) serum dehydroepiandrosterone less than 0.5 nmol/l --prior/concurrent therapy-- no concurrent investigational drug stable glucocorticoid/mineralocorticoid dose over past year required --patient characteristics-- hepatic: no hepatic disease cardiovascular: no vascular disease no thrombotic disorder no angina no elevated blood pressure on 2 readings taken 15 minutes apart in 1 visit, i.e.: systolic greater than 165 mm hg or diastolic greater than 95 mm hg other: no clinically significant medical abnormality no gallbladder disease no malignancy no estrogen- or androgen-dependent neoplasia benign prostatic hyperplasia eligible no other endocrine disease controlled thyroid disease with normal thyroid-stimulating hormone eligible mammogram required within 1 year prior to entry for women aged 40 and over no clinically significant abnormality no undiagnosed vaginal or uterine bleeding within 6 months prior to entry pap smear required within 1 year prior to entry no dysplasia (squamous intraepithelial lesion low-grade or higher)

Keywords: addison's disease endocrine disorders rare disease primary adrenal insufficiency
liberal versus restrictive transfusion strategy in patients with upper git bleeding

Conditions: Upper Git Bleeding

Summary: comparison between the effects and results of the two strategies of blood transfusion, liberal and restrictive in patients with upper git bleeding

comparison between safety, efficacy and mortality rate in the two strategies of blood transfusion, liberal(target hb 9-11g/dl) and restrictive(target hb 7-9 g/dl )in patients with upper git bleeding in sohag university hospital, and how other risk factors as liver cirrhosis , ckd,and cause of bleeding in the patient affect results and expected complications that may be occur after blood transfusion

Eligibility criteria:
inclusion criteria: * all patients presented by upper git bleeding and their cbc show anemia and need blood transfusion exclusion criteria: * all patients less than 18 years and patients have anemia and received blood transfusion by another causes other than git bleeding
investigation on safety, tolerability and pharmacokinetics of multiple doses of nnc0113-0987 in an oral formulation in healthy subjects

Conditions: Diabetes; Healthy

Summary: this trial is conducted in europe. the aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of nnc0113-0987 in an oral formulation in healthy subjects.


Eligibility criteria:
inclusion criteria: * male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator * age 18-64 years (both inclusive) at the time of signing informed consent * body mass index (bmi): 20.0-29.9 kg/m\^2 (both inclusive) exclusion criteria: * history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * history of chronic pancreatitis or idiopathic acute pancreatitis * subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy * use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. occasional use of paracetamol or acetylsalicylic acid is permitted
effectiveness of novel approaches to radical cure with tafenoquine and primaquine

Conditions: Vivax Malaria; Plasmodium Vivax; Malaria, Vivax; Malaria Relapse

Summary: health care facility based, randomized, controlled, open label, superiority trial with 3 arms

* to assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days). * to assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen. * to assess the safety of tafenoquine compared to the high and low dose primaquine regimens. * to assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Eligibility criteria:
inclusion criteria * p. vivax peripheral parasitaemia (mono-infection) as determined by microscopy * g6pd normal status (g6pd activity ≥ 70% of the adjusted male median as determined by the biosensor™ (sd biosensor, rok)) * fever (temperature ≥37.5⁰c) or history of fever in the preceding 48 hours * age ≥18 years * written informed consent * living in the study area and willing to be followed for six months exclusion criteria: * danger signs or symptoms of severe malaria * anaemia (defined as hb \<8g/dl) * pregnant or lactating females * known hypersensitivity to any of the study drugs * regular use of drugs with haemolytic potential

Keywords: tafenoquine primaquine
effects of mandala coloring on anxiety and quality of life of women in the climacteric period

Conditions: Anxiety; Climactericum

Summary: this research was planned as a randomized controlled experimental study in order to reduce the anxiety felt and improve the quality of life by women in the climacteric period.

climacteric period; it is a life process in which the ovarian hormone and activity ends with a decrease, and the transition from the reproductive period to the non-reproductive period takes place, and includes perimenopause, menopause and postmenopausal stages. during the menopausal transition period, women experience many physical and psychological symptoms such as vasomotor symptoms, sleep disorders, depressed mood, and stress that negatively affect their quality of life. when the literature is examined, it can be seen that these menopausal symptoms experienced by women affect and trigger anxiety. effective management of anxiety, which can negatively affect psychosocial well-being, social relations and mood, trigger or exacerbate menopausal symptoms, can improve the quality of life of women in the climacteric period. therefore, anxiety management can be effective for women to cope with menopausal symptoms. carl gustav jung, a swiss psychiatrist, discovered the therapeutic effect of coloring mandala, which is one of the art therapy methods in reducing anxiety. when the studies are examined, there have been many studies investigating the effect of mandala coloring on reducing anxiety. curry and kasser (2005), van der vennet and serice (2012), flet et al (2017) stated that coloring mandala reduces anxiety on students; gürcan and atay turhan (2021) and yakar et al (2021) found that it reduces anxiety and depression in cancer patients; khademi et al (2021) reported that it reduced anxiety in hospitalized covid-19 patients; amelia et al (2020) found that it reduced anxiety in pregnant women. when the studies are examined, there are studies showing that coloring mandala reduces anxiety in cancer patients, children, and pregnant women, but no study has been found on the effect of reducing anxiety related to menopausal symptoms and improving the quality of life of women in the climacteric period. this research was planned as a randomized controlled experimental study in order to reduce the anxiety felt and improve the quality of life by women in the climacteric period.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * fully answering survey and scale forms. * ability to read and understand turkish * being in the climacteric period (42-65 years) * having 40 or more from stai exclusion criteria: * unwilling to continue working * having any problem that prevents communication (such as hearing, speaking, and understanding abilities), * taking medication for menopausal symptoms * using one of the pharmacological or non-pharmacological methods to reduce anxiety and receiving psychiatric treatment (pharmacotherapy or psychotherapy). * surgical menopause * having a mental illness

Keywords: climacterium anxiety quality of life mandala coloring
global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers

Conditions: Facial Wrinkles

Summary: the aim of this study is to assess performance and tolerance as well as investigator and subject satisfaction linked to the global management of facial rejuvenation with a new range of hyaluronic acid dermal fillers.

the range of fillers tested in this study includes 5 different hyaluronic acid dermal fillers: emervel touch, emervel classic, emervel deep, emervel volume and emervel lips. the study will last 6 month. injections will be performed at baseline. if necessary, the investigator will perform touch-up injections at the following visit (3 weeks later). investigator and subject satisfaction will be collected through questionnaires.

Eligibility criteria:
inclusion criteria: * seeking tissue augmentation treatment on the face, * presenting a score of 3 (moderately deep wrinkle)or 4 (deep wrinkle) on the lemperle rating scale (lrs) of both nasolabial folds. exclusion criteria: * at risk in term of precautions, warnings and contra-indication referred in the package insert of the study devices, * who underwent previous injection of permanent filler in the injected area.

Keywords: facial wrinkle correction
durvalumab combined with chemotherapy and stereotactic body radiotherapy (sbrt) in patients with oligometastatic non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this is a phase ii, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (sbrt) in patients with oligo-metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer * ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node * metastasis一group lymph node region will be classified as one metastatic lesion） * tissue biopsy prior to treatment * ecog performance score 0-1 exclusion criteria: * egfr mutation or alk positive. * evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia. * active infection including tuberculosis, hepatitis b, hepatitis c, or human immunodeficiency virus. * previous treatment with antibody against pd -1, pd - l1, pd - l2, cd137 or ctla-4 (including ipilimumab or any antibody or drug against t cell co-stimulation or checkpoint pathway).